Intravascular Membrane Oxygenator Catheter Systems and Methods

Abstract

Intravascular membrane oxygenator catheter systems and methods are disclosed, along with methods of making and using the same. A catheter system includes a catheter shaft having a wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen, a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft, the hollow fiber membrane loops are nonporous with solid walls; a pneumatic source in pneumatic communication with the hollow fiber membrane loops. The pneumatic source provides a gas containing oxygen at a pressure sufficient to cause a diffusive flux of the gas containing oxygen from an interior of the hollow fiber membrane loops to a fluid exterior to the hollow fiber membrane loops in a region of interest of a subject.

1 . A catheter system comprising:
 a catheter shaft having a wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen;   a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft, the plurality of hollow fiber membrane loops are nonporous with solid walls; and   a pneumatic source in pneumatic communication with the plurality of hollow fiber membrane loops;   wherein the pneumatic source is configured to provide a gas containing oxygen at a pressure sufficient to cause a diffusive flux of the gas containing oxygen from an interior of the plurality of hollow fiber membrane loops to a fluid exterior to the plurality of hollow fiber membrane loops in a region of interest of a subject, wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 1 pounds per square inch (PSI).   
     
     
         2 . The catheter system of  claim 1  further comprising a pneumatic control system in pneumatic communication with the pneumatic source and the plurality of hollow fiber membrane loops, the pneumatic control system having a controller configured to provide pressure, temperature, and flow rate control of the gas containing oxygen to the plurality of hollow fiber membrane loops. 
     
     
         3 . The catheter system of  claim 1 , wherein the pneumatic source is an oxygen source. 
     
     
         4 . The catheter system of  claim 1 , wherein the distal end of the catheter shaft is dimensioned for positioning in the region of interest of the subject. 
     
     
         5 . The catheter system of  claim 1 , wherein the catheter system is dimensioned for intravascular placement using a percutaneous approach. 
     
     
         6 . The catheter system of  claim 1 , wherein the region of interest is an inferior vena cava of the subject. 
     
     
         7 . The catheter system of  claim 1 , wherein the region of interest is a right atrium of the subject's heart. 
     
     
         8 . The catheter system of  claim 1 , wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure from 1 to 2400 pounds per square inch (PSI). 
     
     
         9 . The catheter system of  claim 1 , wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 2400 pounds per square inch (PSI). 
     
     
         10 . The catheter system of  claim 1  further comprising a manifold within the lumen, the manifold receives the plurality of hollow fiber membrane loops and supports the plurality of hollow fiber membrane loops at constant distances within the lumen. 
     
     
         11 . The catheter system of  claim 1 , wherein the plurality of hollow fiber membrane loops comprise an amorphous fluoropolymer material. 
     
     
         12 . The catheter system of  claim 1 , wherein the plurality of hollow fiber membrane loops are arranged in parallel loops having an inlet side and a return side, each inlet and return side being potted in a manifold connected to the catheter shaft. 
     
     
         13 . The catheter system of  claim 1 , wherein the plurality of hollow fiber membrane loops comprise between 2 and 500 individual hollow fiber loops. 
     
     
         14 . The catheter system of  claim 1 , wherein the plurality of hollow fiber membrane loops are between 100 micrometers (μm) and 1800 micrometers (μm) in diameter and have a wall thickness of between 10 micrometers (μm) and 500 micrometers (μm). 
     
     
         15 . The catheter system of  claim 1 , wherein the catheter system is configured to deliver at least 0.15 mL of O 2  per minute. 
     
     
         16 . The catheter system of  claim 1 , wherein the catheter system is configured to deliver between 100 ml of O 2  per minute and 200 mL of O 2  per minute. 
     
     
         17 . The catheter system of  claim 1 , wherein the plurality of hollow fiber membrane loops are configured to be subjected to vibration induced from external energies to reduce the accumulation and adherence of bubbles to the plurality of hollow fiber membrane loops allowing more oxygen to be dissolved. 
     
     
         18 . A method of intravascular oxygenation, the method comprising:
 a) introducing a catheter system to a region of interest in a subject, the catheter system comprising
 a catheter shaft having a tubular wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen; 
 a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft; 
 a pneumatic source in pneumatic communication with the plurality of hollow fiber membrane loops; 
 the plurality of hollow fiber membrane loops are nonporous; and 
   b) providing a gas containing oxygen at a pressure from the pneumatic source to the plurality of hollow fiber membrane loops, thereby creating a diffusive flux causing the gas containing oxygen to diffuse from an interior of the plurality of hollow fiber membrane loops to a fluid flowing past an exterior of the plurality of hollow fiber membrane loops in a region of interest of a subject, wherein the pressure is at least 1 pounds per square inch (PSI).   
     
     
         19 . The method of  claim 18 , wherein the pneumatic source of step a) is an oxygen source. 
     
     
         20 . The method of  claim 18 , the method further comprising: delivering at least 0.15 mL of O 2  per minute to the subject via the catheter system. 
     
     
         21 . The catheter system of  claim 1 , wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 25 pounds per square inch (PSI).